As the cosmetic facility registration and product listing requirement date approaches (29 December 2023), companies needing to register their facility, or list cosmetic products should be gathering the information required to submit to FDA.
For facilities that need to register [every person who owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States], the immediate action should be obtaining the FEI (FDA establishment identifier) in preparation for registration submission. Facilities can search the FDA’s FEI portal to see if it already has one assigned. If not in the database, facilities can request an FEI by contacting the FDA. For assistance with this process, EAS is here to help. In addition to obtaining the FEI, you should be pulling together the information detailed in FDA’s Guidance Document that was published in August.
Companies that need to list cosmetic products [Responsible person: the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product] should be pulling together the information detailed for listings in FDA’s Guidance Document.
The FDA continues to issue information for companies to continue their preparation. On Friday 13 October 2023, the FDA issued an update to the Structured Product Labeling (SPL) Implementation Guide with Validating Procedures. The cosmetic section can be found in 3.4 Cosmetic Products on page 95 of the guide. A review may be helpful, but also has the potential to be overwhelming with the extremely technical details of a system many are not yet familiar with. For companies intending to use FDA’s Cosmetics Direct, the program is expected to be very user friendly and walk you through the SPL creation. For companies planning to use FDA’s XForms and ESG submission, or another industry program the guide will be very helpful.
If you have questions or need assistance with pulling your information together, please contact Victoria Pankovich at EAS. vpankovich@easconsultinggroup.com
Posted in Cosmetics, FDA and USDA Regulatory Update and tagged MoCRA.